A&O Shearman

This Practice Note provides an overview of the EU legal regime for paediatric medicines. It discusses the obligations and incentives to stimulate the development of paediatric medicines, including the paediatric investigation plan (PIP), the paediatric studies, the paediatric-use marketing authorisation (PUMA), the paediatric extension (PE), the orphan reward, the regulatory data and marketing protection, the partial fee exemption, as well as research funding, free scientific advice and protocol assistance. This Practice Note also explains the post-authorisation obligations, such as the obligation to place on the market, the annual deferral reports and the publication of paediatric studies. It finally introduces the sanctions imposed on companies which do not comply with the obligations on paediatric medicines.

This Practice Note provides an overview of the EU and UK legal regimes for paediatric medicines. It discusses the obligations and incentives to stimulate the development of paediatric medicines, including the paediatric investigation plan (PIP), the paediatric studies, the paediatric-use marketing authorisation (PUMA), the paediatric extension (PE), the orphan reward, the regulatory data and marketing protection, the partial fee exemption, as well as research funding, free scientific advice and protocol assistance. This Practice Note also explains the post-authorisation obligations, such as the obligation to place on the market, the annual deferral reports and the publication of paediatric studies. It finally introduces the sanctions imposed on companies which do not comply with the obligations on paediatric medicines. It further includes a brief overview of the US framework and key international standard developments.

This Practice Note provides an overview of the EU protection mechanisms and incentives for medicinal products, known as pharmaceutical incentives. They include the supplementary protection certificates (SPCs), regulatory data protection and market protection, market exclusivity for orphan medicinal products and the incentives for paediatric medicines. This Practice Note also discusses how the pharmaceutical incentives interact in practice and the proposals for a review of their regime.